The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco P.a.p. - Quant Diagnostic Kit.
Device ID | K810232 |
510k Number | K810232 |
Device Name: | LEECO P.A.P. - QUANT DIAGNOSTIC KIT |
Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
Applicant | LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JFH |
CFR Regulation Number | 862.1020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-27 |
Decision Date | 1981-02-10 |